79C3C34C52B45572883A05D425EB0F82
Opinion on Incidental Findings in Research and Clinical Practice (2015)
http://www.bioethics.gr/images/pdf/GNOMES/OPINION_Incidental_Findings_FINAL_.pdf
http://leaux.net/URLS/ConvertAPI Text Files/EDEB91196E2095313CDFC249B40D8FFE.en.txt
Examining the file media/Synopses/EDEB91196E2095313CDFC249B40D8FFE.html:
This file was generated: 2020-12-01 05:54:14
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator party:
(return to top)
p.000002:
p.000002:
p.000002: Translation: Matina Chatzigianni
p.000002:
p.000002:
p.000002: HELLENIC NATIONAL BIOETHICS COMMISSION
p.000002: Neofytou Vamva 6, P.C. 10674 Athens
p.000002: Tel.: 0030 210- 88.47.700, Fax: 0030 210- 88.47.701
p.000002: E-mail: secretariat@bioethics.gr, url: www.bioethics.gr
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: I. Introduction
p.000002:
p.000002: The Hellenic National Bioethics Commission reviewed the issue of "incidental findings" which may arise during
p.000002: research in human subjects or medical tests. In recent years, this issue has been a major cause for
p.000002: concern due to the new technologies which have been developed and are already being applied both in
p.000002: medicine and genetics.
p.000002: The term “incidental findings” refers to the findings of a medical test or research, which are (possibly)
p.000002: significant for the subject's health or reproduction and are coincidentally discovered, without falling under the
p.000002: original purpose of the test or research.
p.000002: The greatest challenge posed by incidental findings is to strike a balance between informing the interested
p.000002: party and his/her right "not-to-know", regarding data on his/her health, namely when there is a scientific
p.000002: uncertainty about the implications of incidental findings on one’s health.
p.000002:
p.000002:
p.000002: ΙI. The data
p.000002:
p.000002: Massively parallel DNA-sequencing technologies allow for the simultaneous study of many or all the genes of the
p.000002: human genome within a short period of time and, as a matter of fact, simultaneously in samples from different
p.000002: individuals. The cost of these technologies is gradually reducing, which results in their application not only in
p.000002: research but also in clinical practice.
p.000002: As a result, a great volume of incidental findings is produced, the importance of which covers a wide range. These are
p.000002: classified as follows:
p.000002: a) Pathogenic findings. These are gene mutations which are certain to cause a disease or DNA variants which
p.000002: are associated, to a certain extent, with predisposition to a disease.
p.000002: b) Non-pathogenic findings. These are DNA variants which do not have a direct impact on the pathogenicity of
p.000002: the individual. Nonetheless, there are certain cases where some non-pathogenic findings are indirectly linked
p.000002: to an individual’s
p.000002:
p.000003: 3
p.000003:
p.000003: health: i. findings showing that the individual is healthy but carries a mutation with an autosomal recessive mode
p.000003: of inheritance which can, however, play a role in his/her reproduction decisions since these findings can have
p.000003: an impact on the health of his/her offspring, and ii. The incidental discovery of non-paternity, which does not have a
p.000003: direct impact on the individual's health, but is crucial for the individual to know his/her genetic
...
p.000003: information, regardless of whether he/she faces a particular health problem. This right is reasonably concluded by
p.000003: the fundamental rights to health (both individual and social), which are constitutionally
p.000003: recognized, as well [Articles 5(5), 21(3) of the Constitution].
p.000003: In addition to this general right, especially a person who recourses with his/her own will to health
p.000003: services (for therapeutic, diagnostic or preventive purposes), must have full control over the relevant
p.000003: information that he/she receives from the physician. One usually seeks this kind of information, in order to be able to
p.000003: decide about the conduct of medical acts, pursuant to the fundamental principle of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: “informed consent”1. The control in question is exerted in -even exceptional- cases, where the individual, although
p.000004: he/she wishes the conduct of medical acts, explicitly denies information, thus, authorizing the physician to proceed to
p.000004: the necessary acts at the latter’s own discretion. The possibility of this refusal has been recognized in modern
p.000004: medical ethics and law under the term “right not-to-know” or “right to ignorance”2. Therefore, an
p.000004: individual’s “consent” has a double meaning: it concerns both the choice of a medical act (for which
p.000004: there has been prior relevant information) and the information itself.
p.000004: In the case of incidental findings, the interested party is by definition unable to express his/her will in
p.000004: advance, neither for general nor for specific information. The “activation” of his/her will exclusively
p.000004: depends on the physician’s (or the researcher’s) initiative. Nonetheless, the wish of ‘’information’’ or
p.000004: ‘’ignorance’’ cannot be outright presumed. The Commission holds that here lies the basic moral dilemma of the return or
p.000004: not of incidental findings.
p.000004: 2. The second -absolutely relevant- issue concerns the extent of the physician’s3 or the
p.000004: researcher’s “duty to tell the truth”. Supposing that this duty prevails over the individual’s
p.000004: autonomy, then, regardless of the latter’s will, incidental findings would have to be returned. The
p.000004: Commission considers, however, that the principle of autonomy prevails and, therefore, the duty to tell the
p.000004: truth becomes meaningful only once the interested person has an active will to be informed. The problem of
p.000004: incidental findings lies in the fact that, even though such a will exists, it only covers findings generated by means
p.000004: of a particular test as opposed to other ones.
p.000004: 3. Another issue refers to the management of incidental findings as sensitive data. The Commission deems that knowledge
p.000004: of such data by a third party, while the interested person doesn’t know, renders the former par excellence
p.000004: responsible for their safety. Any processing of these data must be excluded, until the interested party is
p.000004: informed -once he/she wishes it. This also applies for the return of incidental
p.000004:
p.000004: 1 See Article 5 of the Oviedo Convention, Articles 11, 12 of the Code of Medical Ethics (Law
p.000004: 3418/2005).
p.000004: 2 See Article 10(2) of the Oviedo Convention, Article 11(2) of the Code of Medical Ethics.
p.000004: 3 See Article 11(1) of the Code of Medical Ethics.
p.000004:
p.000005: 5
p.000005:
p.000005: findings back to the interested party’s relatives, except for the case when he/she has allowed it, even in the
p.000005: case that him/herself refused to be informed about the findings4. If the interested party exercises his/her
p.000005: right to ignorance, these data must be immediately destroyed.
p.000005: 4. Especially the return of non-paternity findings upon genetic testing, raises a serious moral issue. In this case,
p.000005: there is a conflict between protecting one’s family life (especially to the interest of the child who could definitely
p.000005: suffer from a possible rupture in the parents’ relationship) and, again, protecting the interest of the child to be
p.000005: informed about his/her biological identity. These are fundamental values that conflict each other, and
p.000005: this conflict has not been specifically addressed by law in this field.
p.000005:
p.000005:
p.000005: ΙV. Recommendations
p.000005:
p.000005: Considering the above, the Commission shall commence from the principle of the physician’s duty to tell the truth
p.000005: towards the patient. Accordingly, the researcher also owes to reveal the truth to the participant in
p.000005: a biomedical research. Nevertheless, this duty is activated by the patient’s or the research participant’s right
p.000005: to self-determination, by his/her explicitly expressed wish, that is, to be informed either about specific
p.000005: or about all findings generated by a test. If such a wish has not been expressed, the duty to tell the truth remains
p.000005: inactive.
p.000005: More specifically, the Commission produced the following set of recommendations:
p.000005: 1. The individual’s informed consent to reveal or not the potential incidental findings, which may arise
p.000005: both during research and during a clinical act, is crucial. Consultation between the interested party and the
p.000005: physician or the researcher is deemed necessary prior to any test, in order for the former to be informed about the
p.000005: possibility of incidental findings and understand their potential significance. This will help the interested party
p.000005: to make conscious
p.000005:
p.000005:
p.000005: 4 See Article 11(2) of the Code of Medical Ethics.
p.000005:
p.000006: 6
p.000006:
p.000006: decisions about whether or not he/she wishes to be informed about incidental findings once they are
p.000006: produced.
p.000006: 2. Under this necessary condition, the Commission stresses that the return of incidental findings must,
p.000006: however, be limited to findings of known clinical significance at the time of testing, which must be
p.000006: based on valid scientific data under the attending physician’s or the researcher’s responsibility. The
p.000006: evaluation of the clinical significance of incidental findings shall be subjected to constant reassessment, on
p.000006: the basis of the growing experience of scientists, as well as the consideration of new data and
p.000006: their impact on an individual’s health.
p.000006: 3. However, there are cases of incidental findings with known clinical significance, which are
p.000006: associated with diseases with no available treatment. The Commission notes that the potential return of such
p.000006: findings is at the physician's or the researcher's discretion. Nonetheless, a necessary condition is for the
p.000006: physician or the researcher to have evaluated the scientific data at the time of testing regarding their utility
p.000006: in preventing or delaying the development of a disease.
p.000006: 4. Regarding incidental findings associated with late onset diseases, the Commission deems that
p.000006: the physician or the researcher has the duty to inform the interested adults, only once this information
p.000006: can contribute to decisions about the treatment or the delay of the disease.
p.000006: 5. Once again, the Commission stresses that an exception to points 2,3 and 4 (regarding adults) would be
p.000006: the case where the interested party has explicitly stated during the process of informed consent that he/she does not
p.000006: wish to be informed about any incidental findings (opt-out), thus exercising the right to ignorance.
p.000006: 6. In the case where the patient's or research participant's prior consent is not available, the Commission considers
p.000006: that the physician or the researcher has the duty to inform ad hoc, even on an ex-post basis, the
p.000006: interested party
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: about the presence of incidental findings and act in accordance with the latter's will.
p.000007: 7. As far as children are concerned, informing or not about incidental findings depends on the parents' consent
p.000007: (or whosever exercises parental care). An exception must be made in case the child is deemed mature
p.000007: enough to decide him/herself, in accordance with what applies to consent in any medical act5. Moreover,
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
p.000007: child has the right to access his/her biological identity once he/she reaches adulthood, especially for
p.000007: health reasons, in accordance with what applies for medically assisted reproduction6.
p.000007:
p.000007:
p.000007: Athens, 26 June 2015
p.000007:
p.000007: 5 See Article 12(2)(b) of the Code of Medical Ethics.
p.000007: 6 See Article 1460 of the Civil Code.
p.000007:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000004: 3. Another issue refers to the management of incidental findings as sensitive data. The Commission deems that knowledge
p.000004: of such data by a third party, while the interested person doesn’t know, renders the former par excellence
p.000004: responsible for their safety. Any processing of these data must be excluded, until the interested party is
p.000004: informed -once he/she wishes it. This also applies for the return of incidental
p.000004:
p.000004: 1 See Article 5 of the Oviedo Convention, Articles 11, 12 of the Code of Medical Ethics (Law
p.000004: 3418/2005).
p.000004: 2 See Article 10(2) of the Oviedo Convention, Article 11(2) of the Code of Medical Ethics.
p.000004: 3 See Article 11(1) of the Code of Medical Ethics.
p.000004:
p.000005: 5
p.000005:
p.000005: findings back to the interested party’s relatives, except for the case when he/she has allowed it, even in the
p.000005: case that him/herself refused to be informed about the findings4. If the interested party exercises his/her
p.000005: right to ignorance, these data must be immediately destroyed.
p.000005: 4. Especially the return of non-paternity findings upon genetic testing, raises a serious moral issue. In this case,
p.000005: there is a conflict between protecting one’s family life (especially to the interest of the child who could definitely
p.000005: suffer from a possible rupture in the parents’ relationship) and, again, protecting the interest of the child to be
p.000005: informed about his/her biological identity. These are fundamental values that conflict each other, and
p.000005: this conflict has not been specifically addressed by law in this field.
p.000005:
p.000005:
p.000005: ΙV. Recommendations
p.000005:
p.000005: Considering the above, the Commission shall commence from the principle of the physician’s duty to tell the truth
p.000005: towards the patient. Accordingly, the researcher also owes to reveal the truth to the participant in
p.000005: a biomedical research. Nevertheless, this duty is activated by the patient’s or the research participant’s right
p.000005: to self-determination, by his/her explicitly expressed wish, that is, to be informed either about specific
p.000005: or about all findings generated by a test. If such a wish has not been expressed, the duty to tell the truth remains
p.000005: inactive.
p.000005: More specifically, the Commission produced the following set of recommendations:
p.000005: 1. The individual’s informed consent to reveal or not the potential incidental findings, which may arise
p.000005: both during research and during a clinical act, is crucial. Consultation between the interested party and the
...
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
p.000007: child has the right to access his/her biological identity once he/she reaches adulthood, especially for
p.000007: health reasons, in accordance with what applies for medically assisted reproduction6.
p.000007:
p.000007:
p.000007: Athens, 26 June 2015
p.000007:
p.000007: 5 See Article 12(2)(b) of the Code of Medical Ethics.
p.000007: 6 See Article 1460 of the Civil Code.
p.000007:
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
p.000007: child has the right to access his/her biological identity once he/she reaches adulthood, especially for
p.000007: health reasons, in accordance with what applies for medically assisted reproduction6.
p.000007:
p.000007:
p.000007: Athens, 26 June 2015
p.000007:
p.000007: 5 See Article 12(2)(b) of the Code of Medical Ethics.
p.000007: 6 See Article 1460 of the Civil Code.
p.000007:
...
Social / Child
Searching for indicator child:
(return to top)
p.000004: of such data by a third party, while the interested person doesn’t know, renders the former par excellence
p.000004: responsible for their safety. Any processing of these data must be excluded, until the interested party is
p.000004: informed -once he/she wishes it. This also applies for the return of incidental
p.000004:
p.000004: 1 See Article 5 of the Oviedo Convention, Articles 11, 12 of the Code of Medical Ethics (Law
p.000004: 3418/2005).
p.000004: 2 See Article 10(2) of the Oviedo Convention, Article 11(2) of the Code of Medical Ethics.
p.000004: 3 See Article 11(1) of the Code of Medical Ethics.
p.000004:
p.000005: 5
p.000005:
p.000005: findings back to the interested party’s relatives, except for the case when he/she has allowed it, even in the
p.000005: case that him/herself refused to be informed about the findings4. If the interested party exercises his/her
p.000005: right to ignorance, these data must be immediately destroyed.
p.000005: 4. Especially the return of non-paternity findings upon genetic testing, raises a serious moral issue. In this case,
p.000005: there is a conflict between protecting one’s family life (especially to the interest of the child who could definitely
p.000005: suffer from a possible rupture in the parents’ relationship) and, again, protecting the interest of the child to be
p.000005: informed about his/her biological identity. These are fundamental values that conflict each other, and
p.000005: this conflict has not been specifically addressed by law in this field.
p.000005:
p.000005:
p.000005: ΙV. Recommendations
p.000005:
p.000005: Considering the above, the Commission shall commence from the principle of the physician’s duty to tell the truth
p.000005: towards the patient. Accordingly, the researcher also owes to reveal the truth to the participant in
p.000005: a biomedical research. Nevertheless, this duty is activated by the patient’s or the research participant’s right
p.000005: to self-determination, by his/her explicitly expressed wish, that is, to be informed either about specific
p.000005: or about all findings generated by a test. If such a wish has not been expressed, the duty to tell the truth remains
p.000005: inactive.
p.000005: More specifically, the Commission produced the following set of recommendations:
p.000005: 1. The individual’s informed consent to reveal or not the potential incidental findings, which may arise
p.000005: both during research and during a clinical act, is crucial. Consultation between the interested party and the
p.000005: physician or the researcher is deemed necessary prior to any test, in order for the former to be informed about the
p.000005: possibility of incidental findings and understand their potential significance. This will help the interested party
p.000005: to make conscious
p.000005:
p.000005:
...
p.000006: 4. Regarding incidental findings associated with late onset diseases, the Commission deems that
p.000006: the physician or the researcher has the duty to inform the interested adults, only once this information
p.000006: can contribute to decisions about the treatment or the delay of the disease.
p.000006: 5. Once again, the Commission stresses that an exception to points 2,3 and 4 (regarding adults) would be
p.000006: the case where the interested party has explicitly stated during the process of informed consent that he/she does not
p.000006: wish to be informed about any incidental findings (opt-out), thus exercising the right to ignorance.
p.000006: 6. In the case where the patient's or research participant's prior consent is not available, the Commission considers
p.000006: that the physician or the researcher has the duty to inform ad hoc, even on an ex-post basis, the
p.000006: interested party
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: about the presence of incidental findings and act in accordance with the latter's will.
p.000007: 7. As far as children are concerned, informing or not about incidental findings depends on the parents' consent
p.000007: (or whosever exercises parental care). An exception must be made in case the child is deemed mature
p.000007: enough to decide him/herself, in accordance with what applies to consent in any medical act5. Moreover,
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
p.000007: child has the right to access his/her biological identity once he/she reaches adulthood, especially for
p.000007: health reasons, in accordance with what applies for medically assisted reproduction6.
p.000007:
p.000007:
p.000007: Athens, 26 June 2015
p.000007:
p.000007: 5 See Article 12(2)(b) of the Code of Medical Ethics.
p.000007: 6 See Article 1460 of the Civil Code.
p.000007:
...
Searching for indicator children:
(return to top)
p.000006: associated with diseases with no available treatment. The Commission notes that the potential return of such
p.000006: findings is at the physician's or the researcher's discretion. Nonetheless, a necessary condition is for the
p.000006: physician or the researcher to have evaluated the scientific data at the time of testing regarding their utility
p.000006: in preventing or delaying the development of a disease.
p.000006: 4. Regarding incidental findings associated with late onset diseases, the Commission deems that
p.000006: the physician or the researcher has the duty to inform the interested adults, only once this information
p.000006: can contribute to decisions about the treatment or the delay of the disease.
p.000006: 5. Once again, the Commission stresses that an exception to points 2,3 and 4 (regarding adults) would be
p.000006: the case where the interested party has explicitly stated during the process of informed consent that he/she does not
p.000006: wish to be informed about any incidental findings (opt-out), thus exercising the right to ignorance.
p.000006: 6. In the case where the patient's or research participant's prior consent is not available, the Commission considers
p.000006: that the physician or the researcher has the duty to inform ad hoc, even on an ex-post basis, the
p.000006: interested party
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: about the presence of incidental findings and act in accordance with the latter's will.
p.000007: 7. As far as children are concerned, informing or not about incidental findings depends on the parents' consent
p.000007: (or whosever exercises parental care). An exception must be made in case the child is deemed mature
p.000007: enough to decide him/herself, in accordance with what applies to consent in any medical act5. Moreover,
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
p.000007: child has the right to access his/her biological identity once he/she reaches adulthood, especially for
p.000007: health reasons, in accordance with what applies for medically assisted reproduction6.
p.000007:
p.000007:
p.000007: Athens, 26 June 2015
p.000007:
...
Social / parents
Searching for indicator parents:
(return to top)
p.000004: responsible for their safety. Any processing of these data must be excluded, until the interested party is
p.000004: informed -once he/she wishes it. This also applies for the return of incidental
p.000004:
p.000004: 1 See Article 5 of the Oviedo Convention, Articles 11, 12 of the Code of Medical Ethics (Law
p.000004: 3418/2005).
p.000004: 2 See Article 10(2) of the Oviedo Convention, Article 11(2) of the Code of Medical Ethics.
p.000004: 3 See Article 11(1) of the Code of Medical Ethics.
p.000004:
p.000005: 5
p.000005:
p.000005: findings back to the interested party’s relatives, except for the case when he/she has allowed it, even in the
p.000005: case that him/herself refused to be informed about the findings4. If the interested party exercises his/her
p.000005: right to ignorance, these data must be immediately destroyed.
p.000005: 4. Especially the return of non-paternity findings upon genetic testing, raises a serious moral issue. In this case,
p.000005: there is a conflict between protecting one’s family life (especially to the interest of the child who could definitely
p.000005: suffer from a possible rupture in the parents’ relationship) and, again, protecting the interest of the child to be
p.000005: informed about his/her biological identity. These are fundamental values that conflict each other, and
p.000005: this conflict has not been specifically addressed by law in this field.
p.000005:
p.000005:
p.000005: ΙV. Recommendations
p.000005:
p.000005: Considering the above, the Commission shall commence from the principle of the physician’s duty to tell the truth
p.000005: towards the patient. Accordingly, the researcher also owes to reveal the truth to the participant in
p.000005: a biomedical research. Nevertheless, this duty is activated by the patient’s or the research participant’s right
p.000005: to self-determination, by his/her explicitly expressed wish, that is, to be informed either about specific
p.000005: or about all findings generated by a test. If such a wish has not been expressed, the duty to tell the truth remains
p.000005: inactive.
p.000005: More specifically, the Commission produced the following set of recommendations:
p.000005: 1. The individual’s informed consent to reveal or not the potential incidental findings, which may arise
p.000005: both during research and during a clinical act, is crucial. Consultation between the interested party and the
p.000005: physician or the researcher is deemed necessary prior to any test, in order for the former to be informed about the
p.000005: possibility of incidental findings and understand their potential significance. This will help the interested party
p.000005: to make conscious
...
p.000006: findings is at the physician's or the researcher's discretion. Nonetheless, a necessary condition is for the
p.000006: physician or the researcher to have evaluated the scientific data at the time of testing regarding their utility
p.000006: in preventing or delaying the development of a disease.
p.000006: 4. Regarding incidental findings associated with late onset diseases, the Commission deems that
p.000006: the physician or the researcher has the duty to inform the interested adults, only once this information
p.000006: can contribute to decisions about the treatment or the delay of the disease.
p.000006: 5. Once again, the Commission stresses that an exception to points 2,3 and 4 (regarding adults) would be
p.000006: the case where the interested party has explicitly stated during the process of informed consent that he/she does not
p.000006: wish to be informed about any incidental findings (opt-out), thus exercising the right to ignorance.
p.000006: 6. In the case where the patient's or research participant's prior consent is not available, the Commission considers
p.000006: that the physician or the researcher has the duty to inform ad hoc, even on an ex-post basis, the
p.000006: interested party
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: about the presence of incidental findings and act in accordance with the latter's will.
p.000007: 7. As far as children are concerned, informing or not about incidental findings depends on the parents' consent
p.000007: (or whosever exercises parental care). An exception must be made in case the child is deemed mature
p.000007: enough to decide him/herself, in accordance with what applies to consent in any medical act5. Moreover,
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000006: can contribute to decisions about the treatment or the delay of the disease.
p.000006: 5. Once again, the Commission stresses that an exception to points 2,3 and 4 (regarding adults) would be
p.000006: the case where the interested party has explicitly stated during the process of informed consent that he/she does not
p.000006: wish to be informed about any incidental findings (opt-out), thus exercising the right to ignorance.
p.000006: 6. In the case where the patient's or research participant's prior consent is not available, the Commission considers
p.000006: that the physician or the researcher has the duty to inform ad hoc, even on an ex-post basis, the
p.000006: interested party
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: about the presence of incidental findings and act in accordance with the latter's will.
p.000007: 7. As far as children are concerned, informing or not about incidental findings depends on the parents' consent
p.000007: (or whosever exercises parental care). An exception must be made in case the child is deemed mature
p.000007: enough to decide him/herself, in accordance with what applies to consent in any medical act5. Moreover,
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000002: the individual. Nonetheless, there are certain cases where some non-pathogenic findings are indirectly linked
p.000002: to an individual’s
p.000002:
p.000003: 3
p.000003:
p.000003: health: i. findings showing that the individual is healthy but carries a mutation with an autosomal recessive mode
p.000003: of inheritance which can, however, play a role in his/her reproduction decisions since these findings can have
p.000003: an impact on the health of his/her offspring, and ii. The incidental discovery of non-paternity, which does not have a
p.000003: direct impact on the individual's health, but is crucial for the individual to know his/her genetic
p.000003: make-up and genealogy, for example to prevent a disease.
p.000003: c) Findings of unknown clinical significance. These include findings whose clinical significance and extent of
p.000003: involvement to a disease are not (fully) known yet.
p.000003: In parallel, traditional diagnostic tests widely employed during clinical practice, such as
p.000003: ultrasounds, Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans, may produce incidental findings
p.000003: which do not fall under the patient’s initial clinical picture but have a diagnostic value or significance
p.000003: for the prevention of a disease.
p.000003: In accordance with the above, it is made clear that not all incidental findings share the same clinical significance
p.000003: for the individual’s health, which must primarily be taken into account both before and after conducting genetic or
p.000003: medical tests.
p.000003:
p.000003:
p.000003: III. The ethical issues
p.000003:
p.000003: 1. For the Commission, respect to the individual’s autonomy on issues regarding his/her health constitutes
p.000003: a position of principle. This means that, in principle, every individual shall enjoy the right of general
p.000003: information, regardless of whether he/she faces a particular health problem. This right is reasonably concluded by
p.000003: the fundamental rights to health (both individual and social), which are constitutionally
p.000003: recognized, as well [Articles 5(5), 21(3) of the Constitution].
p.000003: In addition to this general right, especially a person who recourses with his/her own will to health
p.000003: services (for therapeutic, diagnostic or preventive purposes), must have full control over the relevant
p.000003: information that he/she receives from the physician. One usually seeks this kind of information, in order to be able to
p.000003: decide about the conduct of medical acts, pursuant to the fundamental principle of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: “informed consent”1. The control in question is exerted in -even exceptional- cases, where the individual, although
p.000004: he/she wishes the conduct of medical acts, explicitly denies information, thus, authorizing the physician to proceed to
p.000004: the necessary acts at the latter’s own discretion. The possibility of this refusal has been recognized in modern
p.000004: medical ethics and law under the term “right not-to-know” or “right to ignorance”2. Therefore, an
p.000004: individual’s “consent” has a double meaning: it concerns both the choice of a medical act (for which
p.000004: there has been prior relevant information) and the information itself.
p.000004: In the case of incidental findings, the interested party is by definition unable to express his/her will in
p.000004: advance, neither for general nor for specific information. The “activation” of his/her will exclusively
p.000004: depends on the physician’s (or the researcher’s) initiative. Nonetheless, the wish of ‘’information’’ or
p.000004: ‘’ignorance’’ cannot be outright presumed. The Commission holds that here lies the basic moral dilemma of the return or
p.000004: not of incidental findings.
p.000004: 2. The second -absolutely relevant- issue concerns the extent of the physician’s3 or the
p.000004: researcher’s “duty to tell the truth”. Supposing that this duty prevails over the individual’s
p.000004: autonomy, then, regardless of the latter’s will, incidental findings would have to be returned. The
p.000004: Commission considers, however, that the principle of autonomy prevails and, therefore, the duty to tell the
p.000004: truth becomes meaningful only once the interested person has an active will to be informed. The problem of
p.000004: incidental findings lies in the fact that, even though such a will exists, it only covers findings generated by means
p.000004: of a particular test as opposed to other ones.
p.000004: 3. Another issue refers to the management of incidental findings as sensitive data. The Commission deems that knowledge
p.000004: of such data by a third party, while the interested person doesn’t know, renders the former par excellence
p.000004: responsible for their safety. Any processing of these data must be excluded, until the interested party is
p.000004: informed -once he/she wishes it. This also applies for the return of incidental
p.000004:
p.000004: 1 See Article 5 of the Oviedo Convention, Articles 11, 12 of the Code of Medical Ethics (Law
p.000004: 3418/2005).
p.000004: 2 See Article 10(2) of the Oviedo Convention, Article 11(2) of the Code of Medical Ethics.
p.000004: 3 See Article 11(1) of the Code of Medical Ethics.
p.000004:
p.000005: 5
p.000005:
p.000005: findings back to the interested party’s relatives, except for the case when he/she has allowed it, even in the
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000006: the case where the interested party has explicitly stated during the process of informed consent that he/she does not
p.000006: wish to be informed about any incidental findings (opt-out), thus exercising the right to ignorance.
p.000006: 6. In the case where the patient's or research participant's prior consent is not available, the Commission considers
p.000006: that the physician or the researcher has the duty to inform ad hoc, even on an ex-post basis, the
p.000006: interested party
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: about the presence of incidental findings and act in accordance with the latter's will.
p.000007: 7. As far as children are concerned, informing or not about incidental findings depends on the parents' consent
p.000007: (or whosever exercises parental care). An exception must be made in case the child is deemed mature
p.000007: enough to decide him/herself, in accordance with what applies to consent in any medical act5. Moreover,
p.000007: the Commission reiterates its previous position as expressed in its Opinion on "Direct-To-Consumer (DTC)
p.000007: Genetic Testing" (March 2012), according to which, if there is no medical emergency, asymptomatic
p.000007: children must not be informed about findings associated with late onset diseases.
p.000007: 8. Finally, the Commission highlights that regarding incidental findings of non- paternity, the decision of
p.000007: disclosing them depends, once again, on the interested parties' previous consent. In practice, this would mean
p.000007: that:
p.000007: a) Consent to genetic testing must be written and, in any case, prior to the test. In the consent form, it is proper
p.000007: to pose a relevant question about the wish to specifically return an incidental finding of non-paternity. The consent
p.000007: form must explain the reason behind this question.
p.000007: b) Once the question has not been answered in the consent form prior to conducting the test, the physician
p.000007: or the researcher is entitled to assume that the interested party exercises his/her right to ignorance, in the
p.000007: interest of protecting his/her family life.
p.000007: c) In any case, these findings must be kept in secure archives. The Commission deems that a
p.000007: child has the right to access his/her biological identity once he/she reaches adulthood, especially for
p.000007: health reasons, in accordance with what applies for medically assisted reproduction6.
p.000007:
p.000007:
...
General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000004: ‘’ignorance’’ cannot be outright presumed. The Commission holds that here lies the basic moral dilemma of the return or
p.000004: not of incidental findings.
p.000004: 2. The second -absolutely relevant- issue concerns the extent of the physician’s3 or the
p.000004: researcher’s “duty to tell the truth”. Supposing that this duty prevails over the individual’s
p.000004: autonomy, then, regardless of the latter’s will, incidental findings would have to be returned. The
p.000004: Commission considers, however, that the principle of autonomy prevails and, therefore, the duty to tell the
p.000004: truth becomes meaningful only once the interested person has an active will to be informed. The problem of
p.000004: incidental findings lies in the fact that, even though such a will exists, it only covers findings generated by means
p.000004: of a particular test as opposed to other ones.
p.000004: 3. Another issue refers to the management of incidental findings as sensitive data. The Commission deems that knowledge
p.000004: of such data by a third party, while the interested person doesn’t know, renders the former par excellence
p.000004: responsible for their safety. Any processing of these data must be excluded, until the interested party is
p.000004: informed -once he/she wishes it. This also applies for the return of incidental
p.000004:
p.000004: 1 See Article 5 of the Oviedo Convention, Articles 11, 12 of the Code of Medical Ethics (Law
p.000004: 3418/2005).
p.000004: 2 See Article 10(2) of the Oviedo Convention, Article 11(2) of the Code of Medical Ethics.
p.000004: 3 See Article 11(1) of the Code of Medical Ethics.
p.000004:
p.000005: 5
p.000005:
p.000005: findings back to the interested party’s relatives, except for the case when he/she has allowed it, even in the
p.000005: case that him/herself refused to be informed about the findings4. If the interested party exercises his/her
p.000005: right to ignorance, these data must be immediately destroyed.
p.000005: 4. Especially the return of non-paternity findings upon genetic testing, raises a serious moral issue. In this case,
p.000005: there is a conflict between protecting one’s family life (especially to the interest of the child who could definitely
p.000005: suffer from a possible rupture in the parents’ relationship) and, again, protecting the interest of the child to be
p.000005: informed about his/her biological identity. These are fundamental values that conflict each other, and
p.000005: this conflict has not been specifically addressed by law in this field.
p.000005:
p.000005:
p.000005: ΙV. Recommendations
p.000005:
p.000005: Considering the above, the Commission shall commence from the principle of the physician’s duty to tell the truth
p.000005: towards the patient. Accordingly, the researcher also owes to reveal the truth to the participant in
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| emergency | Public Emergency |
| family | Motherhood/Family |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| parents | parents |
| party | political affiliation |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
Trigger Words
consent
ethics
self-determination
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input